FDA - AI based SaMD
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  • FDA - AI based SaMD
  • Data Governance (DG)
    • DG01 - Define Sets
    • DG02 - Dataset Governance Policies
    • DG03 - Dataset Design Choices
    • DG04 - Dataset Source Information
    • DG05 - Dataset Annotations Information
    • DG06 - Dataset Labels Information
    • DG07 - Dataset Cleaning
    • DG08 - Dataset Enrichment
    • DG09 - Dataset Aggregation
    • DG10 - Dataset Description, Assumptions and Purpose
    • DG11 - Dataset Transformation Rationale
    • DG12 - Dataset Bias Identification
    • DG13 - Dataset Bias Mitigation
    • DG14 - Dataset Bias Analysis Action and Assessment
    • DG15 - Dataset Gaps and Shortcomings
    • DG16 - Dataset Bias Monitoring - Ongoing
    • DG17 - Dataset Bias Special/Protected Categories
  • Technical Documentation (TD)
    • TD01 - Technical Documentation Generated
    • TD02 - Additional Technical Documentation
    • TD03 - Technical Details
    • TD04 - Development steps and methods
    • TD05 - Pre-trained or Third party tools/systems
    • TD06 - Design specification
    • TD07 - System Architecture
    • TD08 - Computational Resources
    • TD09 - Data Requirements
    • TD10 - Human Oversight Assessment
    • TD11 - Pre Determined Changes
    • TD12 - Continuous Compliance
    • TD13 - Validation and Testing
    • TD14 - Monitoring, Function and Control
    • TD15 - Risk Management System
    • TD16 - Changes
    • TD17 - Other Technical Standards
    • TD18 - Ongoing Monitoring System
    • TD19 - Reports Signed
  • Transparency and Provision of Information to Users (TPI)
    • TPI01 - Transparency of the AI System
    • TPI02 - Instructions for Use
  • Human Oversight (HO)
    • HO01 - Human Oversight Mechanism
    • HO02 - Human Oversight Details
    • HO03 - Human Oversight - Biometric Identification Systems
  • Accuracy, Robustness and Cybersecurity (ARC)
    • ARC01 - Accuracy Levels
    • ARC02 - Robustness Assessment
    • ARC03 - Continuous Learning Feedback Loop Assessment
    • ARC04 - Cyber Security Assessment
  • Managing SaMD Lifecycle Support Process - Record Keeping (RK)
    • RK01 - Logging Capabilities
    • RK02 - Logging Traceability
    • RK03 - Logging - Situations that May Cause AI Risk
    • RK04 - Logging - Biometric systems requirements
    • RK05 - Details of Off-the-Shelf Components
    • RK06 - Evaluation Process of Off-the-Shelf Components
    • RK07 - Quality Control Process of Off-the-Shelf Components
    • RK08 - Internal Audit Reports
  • Risk Management System (RMS)
    • RMS01 - Risk Management System in Place
    • RMS02 - Risk Management System Capabilities and Processes
    • RMS03 - Risk Management Measures
    • RMS04 - Testing
    • RMS05 - Residual Risks
    • RMS06 - Full Track of Mitigation Measures
  • Quality Management Principles (QMP)
    • QMP01 - Quality Management System in Place
    • QMP02 - Compliance Strategy stated
    • QMP03 - Design processes
    • QMP04 - Development and QA (Quality Assurance) processes
    • QMP05 - Test and Validation Procedures
    • QMP06 - Technical Standards
    • QMP07 - Data Management Procedures
    • QMP08 - Risk Management System
    • QMP09 - Ongoing Monitoring System
    • QMP10 - Incident Reporting Procedures
    • QMP11 - Communications with Competent Authorities
    • QMP12 - Record Keeping Procedures
    • QMP13 - Resource Management Procedures
    • QMP14 - Accountability Framework
  • Post Market Monitoring System (PMS)
    • PMS01 - Post Market Monitoring System in Place
    • PMS02 - Data Collection Assessment
    • PMS03 - Post Market Monitoring Plan
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  1. Human Oversight (HO)

HO03 - Human Oversight - Biometric Identification Systems

For high-risk AI systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons, the oversight mechanism is to ensure that, in addition, no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons.

Organisations must provide a statement that their human oversight process adheres to the stated principle above.

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Last updated 2 years ago